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The Endophys Blood Pressure Monitor Model BPM-30 is intended to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys PSS3 Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access. The Endophys Blood Pressure Monitor Model BPM-30 monitor is additionally intended for use in transport situations within hospital environments.

The Endophys BPM-30 Blood Pressure Monitor is an electronic device that provides compatibility between a physiological fiber optic blood pressure sensor (transducer) and conventional invasive arterial blood pressure inputs to a standard physiological patient monitor. The device converts the optical transducer data to electrical signals that are interpreted by a conventional patient monitor and/or are displayed directly on the BPM-30. The BPM-30 accurately emulates a fluidic arterial blood pressure transducer and supplies electrical signals to its output that are indistinguishable from a conventional fluidic blood pressure transducer.

The BPM-30 is implemented as a self-contained unit that has a fiber optic transducer connection as an input source and communicates with a patient monitor as its output. The BPM acts to directly emulate the electrical interface characteristics of conventional fluidic blood pressure transducers (that patient monitors are compatible with) while providing much more precise blood pressure data derived from a fiber optic transducer placed within an artery. Electrically emulating a conventional fluidic transducer uniquely allows a fiber optic pressure sensor to be used with a wide variety of existing physiological patient monitors without modification of those monitors. Systolic, diastolic, and mean blood pressure values are also displayed directly on the BPM-30 every four seconds.

The BPM-30 is powered by a standard AC power adapter. The BPM-30 also has an internal battery supply that will automatically recharge and maintain operation during brief (up to 30 minutes) power interruptions. The BPM-30 is used outside of the sterile environment and has standard alerts and alarms.

The BPM-30 has an operating pressure range of -30 to 300 mmHg with an accuracy of ±1 mmHg plus ±1% of reading for pressures ≤ 50 mmHg and within ±3% of reading for pressures ≥ 50 mmHg

The provided text describes a 510(k) premarket notification for the Endophys Blood Pressure Monitor Model BPM-30. It outlines the device's description, intended use, and a comparison to a predicate device (Endophys Blood Pressure Monitor model BPM-20). While it mentions "Performance Data" and lists several types of testing conducted, it does not provide specific acceptance criteria or the reported device performance in terms of accuracy metrics against a ground truth as typically expected for proving the device meets those criteria.

Instead, the performance data section states: "The modified Endophys Blood Pressure Monitor met all specified criteria and did not raise new safety or performance questions. Based on the design verification performance the modified Endophys Blood Pressure Monitor was found to have the safety and effectiveness profile that is similar to the predicate device." This indicates that the device was tested to meet internal design specifications and regulatory standards, and its performance was deemed similar to the previously cleared predicate.

Given the information provided, I cannot construct a table of acceptance criteria and reported device performance with specific numerical accuracy values. The document focuses on regulatory compliance and substantial equivalence to a predicate device, rather than a detailed clinical performance study with defined ground truth and expert evaluation.

However, I can extract the accuracy specification for the device, which would likely form part of its inherent design acceptance criteria.

Here's an attempt to answer the request based only on the provided text, highlighting what is implicitly or explicitly stated and what is missing:

Acceptance Criteria and Device Performance for Endophys Blood Pressure Monitor Model BPM-30

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Endophys Blood Pressure Monitor Model BPM-20) rather than presenting a detailed clinical study for novel performance claims. Therefore, specific numerical acceptance criteria and a detailed breakdown of reported device performance in a clinical setting against a robust ground truth (e.g., expert consensus, pathology) are not explicitly provided in the document.

The document does state the performance specifications of the device, which implicitly serve as acceptance criteria for its design and manufacturing.

1. Table of Acceptance Criteria and the Reported Device Performance

Based on the "Summary of Technical Characteristics as Compared to the Predicate Device" and "Device Description" sections, the key performance specification mentioned is accuracy:

It is important to note that the document does not provide raw data, statistical analyses, or specific clinical study results to demonstrate how these accuracy figures were met in a performance study with a test set. It merely states that the "modified Endophys Blood Pressure Monitor met all specified criteria." The "Performance Data" section lists types of testing (Software Verification, Electrical Safety, EMC, Packaging, Functional Testing) but does not detail the results of these tests in terms of the accuracy specifications.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document lists types of performance data (e.g., functional testing, electrical safety) but does not mention the sample size of a patient-based test set or a clinical study.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. There is no mention of the origin or nature of data for any performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The document does not describe a study involving expert readers or the establishment of ground truth in a clinical context (e.g., for interpretation of medical images). The testing appears to be primarily engineering verification and validation against technical specifications rather than a comparative clinical performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/None specified. Since there's no mention of a clinical test set requiring expert interpretation or adjudication, this information is not relevant to the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device described (Blood Pressure Monitor) is not an AI-assisted diagnostic device that would typically undergo an MRMC study. It is a measurement device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly. The accuracy specifications (±1 mmHg plus ±1% of reading for pressures ≤ 50 mmHg, and within ±3% of reading for pressures ≥ 50 mmHg) are for the device itself, implying its standalone measurement performance. This is typically established through bench testing and calibration, which aligns with "Functional Testing" mentioned in the "Performance Data" section.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a blood pressure monitor, the ground truth would typically be established by a highly accurate reference blood pressure measurement device (e.g., a calibrated pressure transducer or manometer) or a standardized pressure source in a laboratory setting. The document does not explicitly state the type of ground truth, but it would align with calibrated reference measurements used during functional and design verification testing.

8. The sample size for the training set

Not applicable/Not specified. This device is a traditional medical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML device that requires a training set.

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The Endophys Blood Pressure Monitor Model 651 is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.

The Endophys Blood Pressure Monitor Model 651 is a blood pressure computer that computes and continuously displays systolic, diastolic and mean blood pressure values. The BPM obtains an optical signal from the Endophys Pressure Sensing Sheath, which is a standalone catheterization sheath that is inserted percutaneously during intravascular diagnostic or interventional procedures. The BPM converts the optical transducer data to electrical signals and displays blood pressure measurements.

The Endophys Blood Pressure Monitor Model 651 is powered by a standard AC power adapter. The Endophys Blood Pressure Monitor Model 651 is used outside of the sterile environment and has standard alerts and alarms.

The Endophys Blood Pressure Monitor Model 651 has an operating pressure range of 0-300 mmHg with an accuracy of ±2mmHg or ±4% of the reading, whichever is greater.

The provided document is a 510(k) premarket notification letter and summary for a Blood Pressure Monitor. It outlines the device's indications for use, technological characteristics, and performance data provided to support substantial equivalence to a predicate device.

However, the request asks for information related to a study proving a device (presumably an AI/imaging device, given the context of "human readers" and "ground truth" derived from experts) meets acceptance criteria, specifically for applications like those that might involve image analysis or disease detection.

The provided document describes a Blood Pressure Monitor, which is a physiological measurement device, not an AI-assisted diagnostic imaging device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to the type of device described in the input text.

The acceptance criteria and performance data for a blood pressure monitor would typically involve accuracy against a reference standard, electrical safety, electromagnetic compatibility, and functional testing, as mentioned in the document. It does not involve AI model performance metrics like sensitivity, specificity, or AUC, nor does it involve human expert ground truth establishment for image interpretation.

Given this fundamental mismatch, I can only provide information relevant to the blood pressure monitor based on the provided text, recognizing that it addresses very different types of acceptance criteria and study methodologies than those implied by the prompt's structured questions.

Based on the provided document (K160945 for the Endophys Blood Pressure Monitor, Model 651), the following is applicable:

The device is a Blood Pressure Monitor, not an AI/imaging device requiring multi-reader studies or complex ground truth establishment by experts for diagnostic interpretation. Its acceptance criteria and performance studies are focused on its accuracy in measuring blood pressure and its electrical and safety compliance.

Acceptance Criteria and Reported Device Performance (for a Blood Pressure Monitor)

Study that Proves the Device Meets Acceptance Criteria:

The document states that "The following performance data were provided in support of the substantial equivalence:"

• Functional Testing
• Electrical Safety (IEC 60601-1)
• Electromagnetic compatibility (IEC 60601-1-2)
• Safety and Essential Performance for Invasive blood pressure monitoring equipment (IEC 60601-2-34)

The conclusion states: "The modified Endophys Blood Pressure Monitor Model 651 met all specified criteria and did not raise new safety or performance questions. Based on the design verification performance the modified Endophys Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device."

Addressing the prompt's specific questions with respect to the provided document (and highlighting non-applicability):

1. A table of acceptance criteria and the reported device performance

   • See table above. The document primarily focuses on technical and safety standards compliance and intrinsic accuracy, not clinical diagnostic performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not specified in the document for the performance testing. These are typically design verification/validation tests for electro-mechanical devices, often conducted in-house to demonstrate compliance with standards and specifications. The document does not indicate a clinical study with a patient test set size or data provenance details in the way an AI diagnostic device submission would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   • Not applicable. This device measures blood pressure. "Ground truth" would be established by a primary reference standard source for blood pressure measurement, not by human experts interpreting data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. This pertains to expert consensus for complex diagnostic interpretation, which is not relevant to a blood pressure monitor.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not applicable. This is a standalone physiological measurement device, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • Partially applicable/Re-interpretation: The performance outlined (accuracy, electrical safety, etc.) is the "standalone" performance of the blood pressure monitor device itself. It operates as an algorithm (converting optical transducer data to electrical signals and displaying blood pressure) without human interpretive input beyond observing the displayed values. There's no separate "human-in-the-loop" aspect to its fundamental function for evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Based on standard practices for such devices: The ground truth for blood pressure measurement accuracy would typically be established by comparison to a highly accurate reference blood pressure measurement device (e.g., a manometer calibrated to a known standard, or another validated invasive blood pressure measurement system). It would not be expert consensus, pathology, or outcomes data in this context. The document does not explicitly state the reference method used.

8. The sample size for the training set

   • Not applicable. This is not a machine learning/AI device that requires a "training set" in the common understanding of the term for AI model development.

9. How the ground truth for the training set was established

   • Not applicable. See point 8.

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The Endophys Blood Pressure Monitor is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.

The Endophys Blood Pressure Monitor ("BPM") Model 651 is a blood pressure computer that computes and continuously displays systolic, diastolic, and mean blood pressure values. The BPM obtains an optical signal from the Endophys Pressure Sensing Sheath, which is a stand-alone catheterization sheath that is inserted percutaneously during intravascular diagnostic or interventional procedures. The BPM converts the optical transducer data to electrical signals and displays blood pressure measurements.

The provided text describes a 510(k) premarket notification for the "Endophys Blood Pressure Monitor" (K141615). However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a recognized standard). This document is a regulatory approval letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study against specific acceptance metrics.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document mentions "design verification testing" and "performance testing" but does not provide details on sample sizes for any test sets that would typically assess clinical performance.
• Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not specified. The document focuses on performance relative to predicate devices and general safety/effectiveness, not on a ground truth established by experts for a specific diagnostic task.

4. Adjudication method for the test set

• Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a blood pressure monitor, not an AI/ML diagnostic aid for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not explicitly detailed as a distinct 'standalone' study for an algorithm in the AI/ML sense. However, the device itself "computes and continuously displays systolic, diastolic, and mean blood pressure values" based on an optical signal. The "design verification testing" and "performance testing" would assess this standalone measurement capability. No specific metrics are provided.

7. The type of ground truth used

• The document states the device "continuously provide[s] systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath." The "ground truth" would implicitly be the established accuracy of pressure measurements against a recognized standard (e.g., an invasive catheter-based pressure measurement device or laboratory-calibrated pressure sensors), but this is not explicitly detailed with specific metrics or methodologies in the provided summary.

8. The sample size for the training set

• Not applicable/Not specified. This is not an AI/ML device in the modern sense that involves a separate training phase with a distinct dataset.

9. How the ground truth for the training set was established

• Not applicable. No training set is mentioned for this type of device.

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